Valsartan EG

PACKAGE LEAFLET: INFORMATION FOR THE USER

VALSARTAN EG 40 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What VALSARTAN EG is and what it is used for
2. What you need to know before taking VALSARTAN EG
3. How to take VALSARTAN EG
4. Possible side effects
5. How to store VALSARTAN EG
6. Contents of the pack and other information

1. WHAT VALSARTAN EG IS AND WHAT IT IS USED FOR

VALSARTAN EG belongs to a class of medicines known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. VALSARTAN EG works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
VALSARTAN EG 40 mg film-coated tablets can be used to treat three different conditions:

• in the treatment of high blood pressure in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, this can damage the blood vessels in the brain, heart, and kidneys, and may lead to heart attack, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
• in the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
• in the treatment of symptomatic heart failure in adult patients. VALSARTAN EG is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used, or may be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid buildup. This occurs when the heart muscle is unable to pump blood strongly enough to supply the body's needs.

2. WHAT YOU SHOULD KNOW BEFORE TAKING VALSARTAN EG

Do not take VALSARTAN EG

• if you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from severe liver disease
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you are more than three months pregnant (use of VALSARTAN EG is also advised to be avoided during the first months of pregnancy – see pregnancy section).

If any of these conditions apply to you, do not take VALSARTAN EG
Warnings and precautions
Talk to your doctor or pharmacist before taking VALSARTAN EG

• if you have liver diseases
• if you have severe kidney diseases or are on dialysis
• if you suffer from renal artery stenosis (narrowing of the artery to the kidney)
• if you have recently undergone a kidney transplant (received a new kidney)
• if you are being treated after a heart attack or for heart failure, your doctor may monitor your kidney function
• if you have serious heart problems other than heart failure or heart attack
• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin. Regular monitoring of your blood potassium levels may be necessary.
• if you are under 18 years of age and taking VALSARTAN EG in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines used to lower blood pressure), your doctor may monitor kidney function and blood potassium levels at regular intervals.
• if you suffer from aldosteronism. This is a condition in which the adrenal glands produce excessive amounts of the hormone aldosterone. In this case, use of VALSARTAN EG is not recommended.
• if you have experienced fluid loss (dehydration) caused by diarrhea, vomiting, or high-dose diuretics.
• if you have had swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you experience these symptoms, stop taking this medicine immediately and contact your doctor without delay. You must not restart any other medicine containing valsartan (such as VALSARTAN EG).
• if you are taking other medicines used to treat high blood pressure (see section “Other medicines and VALSARTAN EG” below).
• you must inform your doctor if you think you are pregnant (or if you plan to become pregnant). VALSARTAN EG is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn child if taken during this period (see the pregnancy section).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "Do not take VALSARTAN EG"
Other medicines and VALSARTAN EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The effect of treatment may be affected if VALSARTAN EG is taken together with certain other medicines. Your doctor may consider it necessary to adjust the dose and/or take other precautions or, in some cases, discontinue one of the medicines. This applies to all medicines, including those not requiring a prescription, especially:

• other medicines that lower blood pressure, particularly those that increase fluid elimination (diuretics).
• medicines that increase potassium levels in the blood. These include potassium supplements, potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
• certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• lithium, a medicine used in the treatment of certain psychiatric disorders.
• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of VALSARTAN EG.
• if you are taking an ACE inhibitor or aliskiren (see also information under the heading: "Do not take VALSARTAN EG" and "Warnings and precautions")
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprololo).
• if you are being treated after a heart attack, combination with ACE inhibitors (medicines used to treat heart attack) is not recommended.

VALSARTAN EG with food and drink
VALSARTAN EG can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

• You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking VALSARTAN EG before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of VALSARTAN EG. VALSARTAN EG is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken after this time.
• Inform your doctor if you are breastfeeding or planning to breastfeed. VALSARTAN EG is not recommended during breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

Driving and using machines
Before driving a vehicle, using tools, or operating machinery, make sure you know how VALSARTAN EG affects you. Like many other medicines used to treat high blood pressure, VALSARTAN EG may cause dizziness and affect your ability to concentrate.
VALSARTAN EG contains lactose (milk sugar).
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE VALSARTAN EG

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often do not notice any signs of this condition and many feel as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.

Children and adolescents (aged 6 to 18 years) with high blood pressure
In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once daily. In patients weighing 35 kg or more, the recommended starting dose is 80 mg of valsartan once daily. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg up to a maximum of 320 mg).

Adult patients after a recent heart attack: treatment is generally started as soon as possible within 12 hours after the heart attack, usually beginning with a low dose of 20 mg twice daily. You can obtain the 20 mg dose by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on the dose you individually tolerate.

VALSARTAN EG may be administered together with other treatments for heart attack, and your doctor will decide which treatment is most suitable for you.

Adult patients with heart failure: treatment is generally started with 40 mg twice daily. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on the dose you individually tolerate. VALSARTAN EG may be administered together with other treatments for heart failure, and your doctor will decide which treatment is most suitable for you.

Method of administration
You may take VALSARTAN EG with or without food. The tablet may be divided into equal doses. The tablet should be swallowed with a glass of water. Take VALSARTAN EG at approximately the same time each day.

If you take more VALSARTAN EG than you should
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

If you forget to take VALSARTAN EG
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for the forgotten dose.

If you stop taking VALSARTAN EG
Stopping treatment with VALSARTAN EG may cause your condition to worsen. Do not stop using this medicine unless your doctor tells you to.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Some symptoms require immediate medical attention:
You may experience symptoms of angioedema (a specific allergic reaction), such as:

• swelling of the face, lips, tongue, or throat
• difficulty breathing or swallowing
• hives and itching

If you experience any of these symptoms, consult your doctor immediately.

Adverse reactions are:

Common (may affect up to 1 in 10 people)

• dizziness
• low blood pressure, with or without symptoms such as dizziness and fainting upon standing
• reduced kidney function (sign of renal impairment)

Uncommon (may affect up to 1 in 100 people)

• angioedema (see section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of dizziness (vertigo)
• severely reduced kidney function (sign of acute renal failure)
• muscle cramps, irregular heartbeat (signs of elevated potassium levels in the blood)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• fatigue (tiredness)
• weakness (asthenia)

Not known (frequency cannot be estimated from the available data)

• allergic reactions with skin rash, itching, and hives; symptoms such as fever, joint swelling and pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms may occur (signs of serum sickness)
• red spots (papules), fever, itching (signs of inflammation of blood vessels, also known as vasculitis)
• increased tendency to bleed or bruise (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia)
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which may lead to anemia in more severe cases)
• increased potassium levels in the blood (which may cause muscle cramps and heart rhythm abnormalities in more severe cases)
• increased liver function test values (which may indicate liver damage), including increased bilirubin levels in the blood (which may cause yellowing of the skin and eyes, jaundice, in more severe cases)
• increased blood urea nitrogen and serum creatinine levels (which may indicate kidney dysfunction)
• low sodium levels in the blood (which may cause fatigue, confusion, muscle spasms, and/or seizures in severe cases)

The frequency of some adverse reactions may vary depending on your condition. For example, adverse effects such as dizziness and decreased liver function have been observed less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.
Adverse reactions in children and adolescents are similar to those observed in adults.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VALSARTAN EG

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Do not store VALSARTAN EG at temperatures above 30°C.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What VALSARTAN EG contains
The active substance is valsartan.
Each film-coated tablet of VALSARTAN EG 40 mg contains 40 mg of valsartan.
Excipients in the tablet core are:

• Monohydrate lactose
• Powdered cellulose
• Hypromellose
• Sodium croscarmellose
• Anhydrous colloidal silica
• Magnesium stearate

Excipients in the tablet coating are:

• Hypromellose
• Macrogol 8000
• Titanium dioxide (E 171)
• Talc
• Yellow iron oxide (E 172)

Description of the appearance of VALSARTAN EG and contents of the pack
The film-coated tablets of VALSARTAN EG 40 mg are yellow, round and biconvex in shape.
They have a score line on both sides, which can be used to divide the tablet into equal doses.
The film-coated tablets of VALSARTAN EG 40 mg are packed in PVC/PVDC aluminium blisters containing 10, 14, 28, 30, 50, 56, 90 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
For further information about this medicinal product, please contact the Marketing Authorization Holder.
Responsible persons for batch release
Centrafarm Services B.V., Nieuwe Donk 9, 4879 AC Etten Leur (The Netherlands)
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary (Ireland)
Eurogenerics N.V., Heizel Esplanade Heysel b 22, B-1020 Brussels (Belgium)
LAMP San Prospero S.p.A., Via della Pace, 25/A, I-41300 San Prospero – Modena (Italy)
PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev (Denmark)
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
STADA Arzneimittel GmbH, Muthgasse 36/2, A-1190 Wien (Austria)
STADA Production Ireland, Waterford Road, Clonmel, Co. Tipperary (Ireland)
This medicinal product is authorized in the European Economic Area Member States under the
following names:
Austria: Valsavil 40 mg Filmtabletten
Belgium: Valsartan EG 40 mg filmomhulde tabletten
Bulgaria: Valsavil 40 mg филмирани таблетки
Denmark: Valsavil 40 mg, filmovertrukne tabletter
Finland: Valsarstad 40 mg tabletti, kalvopäälllysteinen
Germany: Valsartan STADA 40 mg Filmtabletten
Ireland: Valtan 40 mg film-coated tablets
Italy: Valsartan EG 40 mg compresse rivestite con film
Luxembourg: Valsartan EG 40 mg comprimés pelliculés
Portugal: Valsartan STADA
Spain: Valsartán Cardio STADA Genéricos 40 mg comprimidos recubiertos con película EFG
Sweden: Valsartore 40 mg filmdragerade tabletter
The Netherlands: Valsartan CF 40 mg, filmomhulde tabletten
This patient information leaflet was last approved in

PACKAGE LEAFLET: INFORMATION FOR THE USER

VALSARTAN EG 80 mg film-coated tablets, 160 mg film-coated tablets, 320 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What VALSARTAN EG is and what it is used for
2. What you need to know before taking VALSARTAN EG
3. How to take VALSARTAN EG
4. Possible side effects
5. How to store VALSARTAN EG
6. Contents of the pack and other information

1. WHAT VALSARTAN EG IS AND WHAT IT IS USED FOR

VALSARTAN EG belongs to a class of medicines known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. VALSARTAN EG works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

VALSARTAN EG 80 mg and VALSARTAN EG 160 mg film-coated tablets can be used
to treat three different conditions:

• for the treatment of high blood pressure in adults and in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, this can damage the blood vessels of the brain, heart and kidneys, and may lead to heart attack, heart failure or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
• for the treatment of adult patients who have recently had a heart attack (myocardial infarction). "Recently" means within 12 hours to 10 days.
• for the treatment of symptomatic heart failure in adult patients. VALSARTAN EG is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used, or may be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling in the feet and legs due to fluid buildup. This occurs when the heart muscle is unable to pump blood strongly enough to supply adequate blood flow to all parts of the body.

VALSARTAN EG 320 mg film-coated tablets can be used

• for the treatment of high blood pressure in adults and in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, this can damage the blood vessels of the brain, heart and kidneys, and may lead to heart attack, heart failure or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. WHAT YOU SHOULD KNOW BEFORE TAKING VALSARTAN EG

Do not take VALSARTAN EG

• if you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you are more than three months pregnant (use of VALSARTAN EG is also not recommended during the first months of pregnancy – see section on pregnancy).

If any of these conditions apply to you, do not take VALSARTAN EG
Warnings and precautions:

• Consult your doctor or pharmacist before taking VALSARTAN EG if you have liver disease
• if you have kidney disease or are on dialysis
• if you suffer from renal artery stenosis (narrowing of the artery to the kidney)
• if you have recently undergone a kidney transplant (received a new kidney)
• if you are being treated after a heart attack or for heart failure, your doctor may monitor your kidney function
• if you have serious heart problems other than heart failure or heart attack
• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing drugs, and heparin. You may need regular monitoring of your blood potassium levels.
• if you are under 18 years of age and taking VALSARTAN EG in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines used to lower blood pressure), your doctor may monitor kidney function and blood potassium levels at regular intervals.
• if you have aldosteronism. This is a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of VALSARTAN EG is not recommended.
• if you have experienced fluid loss (dehydration) due to diarrhoea, vomiting, or high-dose diuretics.
• if you have previously had swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you experience these symptoms, stop taking this medicine immediately and contact your doctor without delay. You must not restart any other medicine containing valsartan (such as VALSARTAN EG).
• if you are taking other medicines used to treat high blood pressure (see section “Other medicines and VALSARTAN EG” below).
• you must inform your doctor if you think you may be pregnant (or planning to become pregnant). VALSARTAN EG is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken during this period (see section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor” (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol) ( VALSARTAN EG 80 mg and VALSARTAN EG 160 mg film-coated tablets) .

Your doctor may monitor your kidney function, blood pressure, and levels of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also the section "Do not take VALSARTAN EG"
Other medicines and VALSARTAN EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
The effect of treatment may be altered if VALSARTAN EG is taken with certain other
medicines. Your doctor may consider it necessary to adjust the dose and/or take other
precautions, or in some cases, discontinue one of the medicines. This applies to any
medicine, including those available without a prescription, particularly:

• other medicines that lower blood pressure, especially those that increase fluid elimination (diuretics).
• medicines that increase potassium levels in the blood. These include potassium supplements, potassium-containing salt substitutes, potassium-sparing drugs, and heparin.
• certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• lithium, a medicine used in the treatment of certain psychiatric disorders.
• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of VALSARTAN EG.
• if you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take VALSARTAN EG" and "Warnings and precautions")
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprololo) ( VALSARTAN EG 80 mg and VALSARTAN EG 160 mg film-coated tablets) .

Additionally for VALSARTAN EG 80 mg and 160 mg:

• if you are being treated after a heart attack, concomitant use with ACE inhibitors (medicines used to treat heart attack) is not recommended.

VALSARTAN EG with food and drink
VALSARTAN EG may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.

• You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant) . Your doctor will usually advise you to stop taking VALSARTAN EG before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of VALSARTAN EG. VALSARTAN EG is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken after this time.
• Inform your doctor if you are breastfeeding or planning to breastfeed . VALSARTAN EG is not recommended during breastfeeding and your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

Driving and using machines
Before driving, operating machinery, or performing other activities requiring
concentration, you should be aware of how you react to VALSARTAN EG. Like many other
medicines used to treat high blood pressure, VALSARTAN EG may cause dizziness and
affect your ability to concentrate.
VALSARTAN EG contains lactose (milk sugar).
If your doctor has diagnosed you with an intolerance to certain sugars, please consult them before taking
this medicine.

3. HOW TO TAKE VALSARTAN EG

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often do not notice any symptoms and may feel perfectly well. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.

VALSARTAN EG 80 mg and VALSARTAN EG 160 mg film-coated tablets
Adult patients with high blood pressure: The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe a higher dose (e.g. 160 mg or 320 mg). Your doctor may also combine VALSARTAN EG with another medicine (e.g. a diuretic).

Children and adolescents (aged 6 to 18 years) with high blood pressure
In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once daily. In patients weighing 35 kg or more, the recommended initial dose is 80 mg of valsartan once daily. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg, up to a maximum of 320 mg).

Adult patients after a recent heart attack: Treatment is usually started as soon as possible, within 12 hours after the heart attack, typically beginning with a low dose of 20 mg twice daily. Your doctor will gradually increase this dose over several weeks, up to a maximum of 160 mg twice daily. The final dose depends on the dose you individually tolerate. VALSARTAN EG may be administered together with other treatments for heart attack, and your doctor will decide which treatment is most suitable for you.

Adult patients with heart failure: Treatment is usually started with 40 mg twice daily. Your doctor will gradually increase this dose over several weeks, up to a maximum of 160 mg twice daily. The final dose depends on the dose you individually tolerate. VALSARTAN EG may be administered together with other treatments for heart failure, and your doctor will decide which treatment is most suitable for you.

VALSARTAN EG 320 mg film-coated tablets
Adult patients with high blood pressure: The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe a higher dose (e.g. 160 mg or 320 mg). Your doctor may also combine VALSARTAN EG with another medicine (e.g. a diuretic).

Children and adolescents (aged 6 to 18 years) with high blood pressure
In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once daily. In patients weighing 35 kg or more, the recommended initial dose is 80 mg of valsartan once daily. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg, up to a maximum of 320 mg).

Method of administration
You may take VALSARTAN EG with or without food. The tablet may be divided into two equal doses. The tablet should be swallowed with a glass of water. Take VALSARTAN EG at approximately the same time each day.

If you take more VALSARTAN EG than you should
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or go to hospital.

If you forget to take VALSARTAN EG
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

If you stop taking VALSARTAN EG
Stopping treatment with VALSARTAN EG may cause your condition to worsen. Do not discontinue use of this medicine unless instructed by your doctor.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some symptoms require immediate medical attention:
You may experience symptoms of angioedema (a specific allergic reaction), such as:

• swelling of the face, lips, tongue or throat
• difficulty breathing or swallowing
• hives and itching

If you experience any of these symptoms, consult your doctor immediately.
The adverse reactions are:
Common (may affect up to 1 in 10 people)

• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• reduced kidney function test values (sign of kidney impairment)

Uncommon (may affect up to 1 in 100 people)

• angioedema (see section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of dizziness (vertigo)
• severely reduced kidney function (sign of acute kidney failure)
• muscle cramps, irregular heartbeat (signs of high potassium levels in the blood)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• fatigue (tiredness)
• weakness (asthenia)

Not known (frequency cannot be estimated from available data)

• allergic reactions with skin rash, itching and hives; symptoms such as fever, swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
• red spots (papules), fever, itching (signs of inflammation of blood vessels also known as vasculitis)
• increased tendency to bleed or bruise (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia)
• decreased haemoglobin levels and decreased percentage of red blood cells in the blood (which may lead to anaemia in more severe cases)
• increased potassium levels in the blood (which may cause muscle cramps and irregular heartbeat in more severe cases)
• increased liver function test values (which may indicate liver damage), including increased bilirubin levels in the blood (which may cause yellowing of the skin and eyes in more severe cases)
• increased blood urea nitrogen (azotemia) and increased serum creatinine levels (which may indicate abnormal kidney function)
• low sodium levels in the blood (which may cause fatigue, confusion, muscle spasms and/or seizures in severe cases)

The frequency of some adverse reactions may vary depending on your condition. For example, effects such as dizziness and decreased liver function test values have been observed less frequently in adult patients treated for high blood pressure compared to adult patients treated for heart failure or after a recent heart attack.
Adverse reactions in children and adolescents are similar to those observed in adults.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VALSARTAN EG

• Do not store VALSARTAN EG above 30°C.
• Keep out of the reach and sight of children.
• Do not use VALSARTAN EG after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
• Do not use VALSARTAN EG if you notice that the packaging is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What VALSARTAN EG contains
The active substance is valsartan.
Each film-coated tablet of VALSARTAN EG 80 mg contains 80 mg of valsartan.
Each film-coated tablet of VALSARTAN EG 160 mg contains 160 mg of valsartan.
Each film-coated tablet of VALSARTAN EG 320 mg contains 320 mg of valsartan.

Excipients in the tablet core:

• Monohydrate lactose
• Microcrystalline cellulose
• Hypromellose
• Sodium croscarmellose
• Anhydrous colloidal silica
• Magnesium stearate

Excipients in the tablet coating:

• Hypromellose
• Polyethylene glycol 8000
• Titanium dioxide (E 171)
• Talc

VALSARTAN EG 80 mg film-coated tablets

• Red iron oxide (E 172)

VALSARTAN EG 160 mg film-coated tablets

• Yellow iron oxide (E 172)

VALSARTAN EG 320 mg film-coated tablets

• Yellow iron oxide (E 172)
• Red iron oxide (E 172)
• Black iron oxide (E 172)

Description of the appearance of VALSARTAN EG and packaging contents
VALSARTAN EG 80 mg film-coated tablets are pink, round and biconvex in shape.
They have a break line on both sides, which can be used to divide the tablet into equal doses.
VALSARTAN EG 80 mg film-coated tablets are packaged in PVC/PVDC aluminium blisters containing 10, 14, 28, 30, 50, 56, 90, 98 and 100 tablets.

VALSARTAN EG 160 mg film-coated tablets are yellow, oblong and biconvex in shape.
They have a break line on both sides, which can be used to divide the tablet into equal doses.
VALSARTAN EG 160 mg film-coated tablets are packaged in PVC/PVDC aluminium blisters containing 10, 14, 28, 30, 50, 56, 90, 98 and 100 tablets.

VALSARTAN EG 320 mg film-coated tablets are brown, oblong and biconvex in shape.
They have a break line on both sides, which can be used to divide the tablet into equal doses.
VALSARTAN EG 320 mg film-coated tablets are packaged in PVC/PVDC aluminium blisters containing 10, 14, 28, 30, 50, 56, 98, 100, 112, 126, 154, 168, 182 and 196 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
For further information about this medicinal product, please contact the Marketing Authorization Holder.

Responsible manufacturers for batch release
Centrafarm Services B.V., Nieuwe Donk 9, 4879 AC Etten Leur (Netherlands)
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary (Ireland)
Eurogenerics N.V., Heizel Esplanade Heysel b 22, B-1020 Brussels (Belgium)
LAMP San Prospero S.p.A., Via della Pace, 25/A, I-41300 San Prospero – Modena (Italy)
PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev (Denmark)
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
STADA Arzneimittel GmbH, Muthgasse 36/2, A-1190 Wien (Austria)
STADA Production Ireland, Waterford Road, Clonmel, Co. Tipperary (Ireland)

This medicinal product is authorized in the European Economic Area countries under the following names:

Austria: Valsavil 80 mg Filmtabletten
Belgium: Valsartan EG 80 mg filmomhulde tabletten
Bulgaria: Valsavil 80 mg филмирани таблетки
Denmark: Valsavil 80 mg, filmovertrukne tabletter
Finland: Valsarstad 80 mg tabletti, kalvopäälllysteinen
Germany: Valsartan STADA 80 mg Filmtabletten
Ireland: Valtan 80 mg film-coated tablets
Italy: Valsartan EG 80 mg compresse rivestite con film
Luxembourg: Valsartan EG 80 mg comprimés pelliculés
Poland: Valsavil
Portugal: Valsartan STADA
Spain: Valsartan STADA Genéricos 80 mg comprimidos recubiertos con pelicula EFG
Sweden: Valsartore 80 mg filmdragerade tabletter
Netherlands: Valsartan CF 80 mg, filmomhulde tabletten

Austria: Valsavil 160 mg Filmtabletten
Belgium: Valsartan EG 160 mg filmomhulde tabletten
Bulgaria: Valsavil 160 mg филмирани таблетки
Denmark: Valsavil 160 mg, filmovertrukne tabletter
Finland: Valsarstad 160 mg tabletti, kalvopäälllysteinen
Germany: Valsartan STADA 160 mg Filmtabletten
Ireland: Valtan 160 mg film-coated tablets
Italy: Valsartan EG 160 mg compresse rivestite con film
Luxembourg: Valsartan EG 160 mg comprimés pelliculés
Poland: Valsavil
Portugal: Valsartan STADA
Spain: Valsartan STADA Genéricos 160 mg comprimidos recubiertos con pelicula EFG
Sweden: Valsartore 160 mg filmdragerade tabletter
Netherlands: Valsartan CF 160 mg, filmomhulde tabletten

Austria: Valsavil 320 mg Filmtabletten
Belgium: Valsartan EG 320 mg filmomhulde tabletten
Bulgaria: Valsavil 320 mg филмирани таблетки
Denmark: Valsavil 320 mg, filmovertrukne tabletter
Finland: Valsarstad 320 mg tabletti, kalvopäälllysteinen
Germany: Valsartan STADA 320 mg Filmtabletten
Ireland: Valtan 320 mg film-coated tablets
Italy: Valsartan EG 320 mg compresse rivestite con film
Luxembourg: Valsartan EG 320 mg comprimés pelliculés
Poland: Valsavil
Portugal: Valsartan STADA
Spain: Valsartan STADA Genéricos 320 mg comprimidos recubiertos con pelicula EFG
Sweden: Valsartore 320 mg filmdragerade tabletter
Netherlands: Valsartan CF 320 mg, filmomhulde tabletten

This summary of product characteristics was last approved on